FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
1993–2016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2025
LED Light Therapy Device (Models: SG-FM, SG-FE)
K253086 · OHS
Sunglor Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 19, 2025
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
K253054 · OHS
Shenzhen Xinlong Precision Plastic...
General & Plastic Surgery · 88d
Cleared Dec 19, 2025
EMPOWR Knee
K252974 · JWH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Dec 19, 2025
SCOUT MD Surgical Guidance System
K252892 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Dec 19, 2025
SANDRO Dual
K252877 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 100d
Cleared Dec 19, 2025
ClearCalc Model RADCA V2.6
K252863 · MUJ
Radformation, Inc.
Radiology · 101d
Cleared Dec 19, 2025
MAGNETOM Sola
K252838 · LNH
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 19, 2025
MSFX MIKRON PEEK CAGES
K252781 · ODP
Mikron Makina Sanayi VE Tic. Ltd. Sti.
Orthopedic · 108d
Cleared Dec 19, 2025
LCD Monitor (CL1902A, CL2103F)
K252780 · PGY
Shenzhen Beacon Display Technology...
Radiology · 108d
Cleared Dec 19, 2025
Wearable Electric Breast Pump (YM-8803)
K252754 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 112d
Cleared Dec 19, 2025
Alzevita
K252670 · QIH
TOPIA MEDTECH LIMITED
Radiology · 116d
Cleared Dec 19, 2025
CE Deliver (DLV)
K252480 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 19, 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
K252342 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 144d
Cleared Dec 19, 2025
eMurmur Heart AI
K252284 · DQD
Csd Labs
Cardiovascular · 150d
Cleared Dec 19, 2025
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling...
K252167 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 162d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Spo2 Sensor CSS032D
K251751 · DQA
Shenzhen Ykd Technology Co., Ltd.
Anesthesiology · 193d
Cleared Dec 19, 2025
LIA Console (542-7)
K251730 · NQQ
Leadoptik, Inc.
General & Plastic Surgery · 196d
Cleared Dec 19, 2025
eRapid with eTrack System
K251572 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 211d
Cleared Dec 19, 2025
Endura™ Ureteral Stent and Stent Set
K251469 · FAD
Cathegenix (Xiamen) Co., Ltd.
Gastroenterology & Urology · 220d
Cleared Dec 19, 2025
LIA-1 Catheter (542-1)
K251402 · KTI
Leadoptik, Inc.
Anesthesiology · 227d
Cleared Dec 19, 2025
DBLG2
K251152 · QJI
Diabeloop
Chemistry · 249d
Cleared Dec 19, 2025
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
K251143 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 249d
Cleared Dec 19, 2025
JOULE 1064nm System and Accessories
K251077 · GEX
Sciton, Inc
General & Plastic Surgery · 255d